GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM

Report

Report Number: 2017233-2022-03383
Event Type: Death
Date Received: October 6, 2022
Date of Event: September 7, 2022
Report Date: October 6, 2022
Manufacturer: W. L. GORE & ASSOCIATES, INC.
Product Code: MIH
PMA / PMN Number: P040043
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

(B)(4). ACCORDING TO THE CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), COMPLICATIONS ASSOCIATED WITH USE OF THE GORE® TAG® THORACIC ENDOPROSTHESIS MAY INCLUDE BUT ARE NOT LIMITED TO AORTIC EXPANSION (FALSE LUMEN), AORTIC RUPTURE, REOPERATION, AND DEATH. SINCE IT IS UNKNOWN WHICH DEVICE IS DIRECTLY IMPLICATED IN THIS COMPLAINT, TGM454515J/SN#(B)(4)/UDI-(B)(4) AND TGMR404020J/SN#(B)(4)/UDI-(B)(4) WILL BE INCLUDED ON THIS REPORT. W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

Description of Event or Problem · 0

THE FOLLOWING INFORMATION WAS REPORTED TO GORE: THIS PATIENT HAD SUFFERED FROM A SYMPTOMATIC CHRONIC AORTIC DISSECTION FOR 10 YEARS. ON (B)(6) 2022, THIS PATIENT UNDERWENT AN EMERGENCY ENDOVASCULAR TREATMENT FOR A THORACIC (ARCH + DESCENDING) AORTIC ANEURYSM AND AN ACUTE TYPE B AORTIC DISSECTION USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM (CTAG ACS). IN TOTAL, THREE CTAG ACS AND A NON-GORE STENT GRAFT WERE IMPLANTED. AT THE END OF THE PROCEDURE, BLOOD FLOW IN THE TRUE LUMEN WAS RECOVERED WITHOUT ANY ENDOLEAKS AND THE PATIENT¿S CONDITION WAS STABLE. ON (B)(6) 2022, A THORACIC AORTIC ANEURYSM RUPTURE OCCURRED. REPORTEDLY, THE RUPTURED SITE WAS WITHIN THE TREATMENT AREA OF THE CTAG ACS, AND THE CAUSE OF THE RUPTURE WAS RE-ENTRY FLOW INTO THE FALSE LUMEN FROM THE DISTAL SITE. THE PATIENT DEVELOPED CARDIOPULMONARY ARREST, AND AN EMERGENCY PROCEDURE WAS PERFORMED WHILE USING EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). TOTAL ARCH REPLACEMENT + OPEN STENT GRAFT TECHNIQUE + DESCENDING AORTA REPLACEMENT WAS PERFORMED. ON (B)(6) 2022, THE PATIENT DIED. THE CAUSE OF DEATH WAS THORACIC AORTIC ANEURYSM RUPTURE. THE REPORTING PHYSICIAN COMMENTED AS FOLLOWS: PLACEMENT OF CTAG ACS IMPROVED LOWER LIMB MALPERFUSION; HOWEVER, IT COULD NOT PREVENT THE THORACIC AORTIC ANEURYSM RUPTURE. THE INITIAL PROCEDURE WAS NOT RELATED TO THE PATIENT¿S DEATH.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2511486	GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM	SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT	MIH	W. L. GORE & ASSOCIATES, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	37 YR	Male	Required Intervention\| H